Open, randomised, monosite pilot trial for comparison of thrombolytic efficacy of tenecteplase and alteplase in patients with acute pulmonary embolism
Phase 1
- Conditions
- Patients with acute pulmonary embolism and indication for thrombolytic therapy are included in the study
- Registration Number
- EUCTR2005-001070-27-AT
- Lead Sponsor
- Division of Angiology Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. written Informed Consent
2. Patients older than 18, younger than 80 years
3. proven pulmonary embolism Grosser II-III
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. contraindikation for thrombolytic therapy
2. pregnant or nursing women
3. planned use of thrombolytica due to an extensive venous thrombosis
4. known incompatibility with Alteplase or Tenecteplase
5. hospitalizationof the patient is more than five hors ago
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the efficacy of the tested substances by size reduction of pulmonary embolism respectively size reduction of the venous thrombus and recurrence rate;Secondary Objective: Evaluation of the safety of the tested substances by occurence of SAEs and SUSARs and severe bleeding complications;Primary end point(s): reduction of the size of pulmonary embolism and venous thrombus measured by magnet resonance phlebography
- Secondary Outcome Measures
Name Time Method